Telemonitoring of Active Inflammatory Bowel Disease Using the App TECCU: Short-Term Results of a Multicenter Trial of GETECCU.

Autor:	Aguas M; Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain.; Health Research Institute La Fe, Valencia, Spain., Del Hoyo J; Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain.; Health Research Institute La Fe, Valencia, Spain., Vicente R; Miguel Servet University Hospital, Zaragoza, Spain., Barreiro-de Acosta M; University Clinical Hospital, Santiago, Spain., Melcarne L; Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain., Hernandez-Camba A; Nuestra Señora de la Candelaria University Hospital, Tenerife, Spain., Madero L; Dr Balmis General University Hospital, ISABIAL, Alicante, Spain.; CIBERehd, Instituto de Salud Carlos III, Madrid, Spain., Arroyo MT; Lozano Blesa Clinic University Hospital, Zaragoza, Spain., Sicilia B; Burgos University Hospital, Burgos, Spain., Chaparro M; CIBERehd, Instituto de Salud Carlos III, Madrid, Spain.; Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid, Madrid, Spain., Martin-Arranz MD; La Paz University Hospital, Faculty of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.; Instituto de Investigación Sanitaria del Hospital Universitario La Paz (IdiPAZ), Madrid, Spain., Pajares R; Infanta Sofía University Hospital, Madrid, Spain., Mesonero F; Ramón y Cajal University Hospital, Madrid, Spain., Mañosa M; CIBERehd, Instituto de Salud Carlos III, Madrid, Spain.; Germans Trias i Pujol University Hospital, Badalona, Spain., Martinez P; San Cecilio Clinic University Hospital, Parque Tecnológico de la Salud, Granada, Spain., Chacón S; Morales Meseguer General University Hospital, Murcia, Spain., Tosca J; Clinic University Hospital, Valencia, Spain., Marín S; Reina Sofía University Hospital, Córdoba, Spain., Sanroman L; Hospital Alvaro Cunqueiro, Vigo, Spain., Calvo M; Puerta de Hierro University Hospital, Madrid, Spain., Monfort D; Consorci Sanitari Terrasa, Barcelona, Spain., Saiz E; Xarxa Assistencial University Hospital, Manresa, Spain., Zabana Y; CIBERehd, Instituto de Salud Carlos III, Madrid, Spain.; Mútua Terrassa University Hospital, Terrassa, Spain., Guerra I; Fuenlabrada University Hospital, Madrid, Spain., Varela P; Cabueñes Universitary Hospital, Gijón, Spain., Baydal V; Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain., Faubel R; Joint Research Unit in ICT Applied to Reengineering Socio-Sanitary Process, IIS La Fe-Universitat Politècnica de València, Valencia, Spain.; Physiotherapy in Motion Multispeciality Research Group (PTinMOTION), Department of Physiotherapy, Universitat de València, Valencia, Spain., Corsino P; Miguel Servet University Hospital, Zaragoza, Spain., Porto-Silva S; University Clinical Hospital, Santiago, Spain., Brunet E; Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain., González M; Nuestra Señora de la Candelaria University Hospital, Tenerife, Spain., Gutiérrez A; Dr Balmis General University Hospital, ISABIAL, Alicante, Spain., Nos P; Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain.; Health Research Institute La Fe, Valencia, Spain.
Jazyk:	angličtina
Zdroj:	Journal of medical Internet research [J Med Internet Res] 2024 Nov 18; Vol. 26, pp. e60966. Date of Electronic Publication: 2024 Nov 18.
DOI:	10.2196/60966
Abstrakt:	Background: Telemonitoring for inflammatory bowel disease (IBD) has not consistently demonstrated superiority over standard care; however, noninferiority may be an acceptable outcome if remote care proves to be more efficient. Objective: This study aims to compare the remission time and quality of life of patients with active IBD managed through standard care versus the TECCU (Telemonitoring of Crohn Disease and Ulcerative Colitis) app. Methods: A 2-arm, randomized, multicenter trial with a noninferiority design was conducted across 24 hospitals in Spain. The study included adult patients with IBD who were starting immunosuppressive or biological therapy. Participants were randomized into 2 groups: the telemonitoring group (G_TECCU) and the standard care group (G_Control). The follow-up schedule for the telemonitoring group (G_TECCU) was based on contacts via the TECCU app, while the control group (G_Control) adhered to standard clinical practice, which included in-person visits and telephone calls. In both groups, treatment adjustments were made based on the progression of disease activity and medication adherence, assessed using specific indices and biological markers at each check-up. The primary outcome was the duration of remission after 12 weeks, while secondary outcomes included quality of life, medication adherence, adverse events, and patient satisfaction. Results: Of the 169 patients enrolled, 158 were randomized and 150 were analyzed per protocol: telemonitoring (n=71) and control (n=79). After 12 weeks, the time in clinical remission was not inferior in the telemonitoring group (mean 4.20, SD 3.73 weeks) compared with the control group (mean 4.32, SD 3.28 weeks), with a mean difference between arms of -0.12 weeks (95% CI -1.25 to 1.01; noninferiority P=.02). The mean reduction in C-reactive protein values was -15.40 mg/L (SD 90.15 mg/L; P=.19) in the G_TECCU group and -13.16 mg/L (SD 54.61 mg/L; P=.05) in the G_Control group, with no significant differences between the 2 arms (P=.73). Similarly, the mean improvement in fecal calprotectin levels was 832.3 mg/L (SD 1825.0 mg/L; P=.003) in the G_TECCU group and 1073.5 mg/L (SD 3105.7 mg/L; P=.03) in the G_Control group; however, the differences were not statistically significant (P=.96). Quality of life improved in both groups, with a mean increase in the 9-item Inflammatory Bowel Disease Questionnaire score of 13.44 points (SD 19.1 points; P<.001) in the G_TECCU group and 18.23 points (SD 22.9 points; P=.001) in the G_Control group. Additionally, the proportion of patients who adhered to their medication significantly increased from 35% (25/71) to 68% (48/71) in the G_TECCU group (P=.001) and from 46% (36/79) to 73% (58/79) in the G_Control group (P=.001). The satisfaction rate remained stable at around 90%, although noninferiority was not demonstrated for the secondary outcomes. Conclusions: Telemonitoring patients with active IBD is not inferior to standard care for achieving and maintaining short-term remission. The TECCU app may serve as a viable alternative follow-up tool, pending confirmation of improved health outcomes and cost-effectiveness over the long-term. Trial Registration: ClinicalTrials.gov NCT06031038; https://clinicaltrials.gov/ct2/show/NCT06031038. International Registered Report Identifier (irrid): RR2-10.2196/resprot.9639. (©Mariam Aguas, Javier Del Hoyo, Raquel Vicente, Manuel Barreiro-de Acosta, Luigi Melcarne, Alejandro Hernandez-Camba, Lucía Madero, María Teresa Arroyo, Beatriz Sicilia, María Chaparro, María Dolores Martin-Arranz, Ramón Pajares, Francisco Mesonero, Miriam Mañosa, Pilar Martinez, Silvia Chacón, Joan Tosca, Sandra Marín, Luciano Sanroman, Marta Calvo, David Monfort, Empar Saiz, Yamile Zabana, Ivan Guerra, Pilar Varela, Virginia Baydal, Raquel Faubel, Pilar Corsino, Sol Porto-Silva, Eduard Brunet, Melodi González, Ana Gutiérrez, Pilar Nos. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 18.11.2024.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu